Combination Therapy for the Treatment of Bipolar Disorders

This study has been terminated.

(F Funding Expiration)

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00063362

First received: June 25, 2003

Last updated: February 8, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2003

Last Updated Date

February 8, 2008

Start Date ^ICMJE

February 2002

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00063362 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Combination Therapy for the Treatment of Bipolar Disorders

Official Title ^ICMJE

Combination Therapy in Bipolar Rapid Cycling

Brief Summary

This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

Detailed Description

Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: Lithium
Drug: Lamotrigine
Drug: Divalproex

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Bipolar I or II Disorder
Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months
Meet criteria for a major depressive episode

Exclusion Criteria:

History of intolerability of lithium, divalproex, or lamotrigine

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00063362

Other Study ID Numbers ^ICMJE

R21 MH62650, DSIR AT-SO

Has Data Monitoring Committee

Yes

Responsible Party

Joseph R. Calabrese, University Hospitals Case Medical Center

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Keming Gao, MD, PhD

Case Western Reserve University / University Hospitals of Cleveland

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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